Interchangeability study of Humira biosimilar enrolls first patient

On July 27, German pharmaceutical company Boehringer Ingelheim announced it had enrolled the first patient in a study intended to demonstrate that a biosimilar is interchangeable with Humira (adalimumab) for treating patients with moderate-to-severe chronic plaque psoriasis.

Ivan Blanarik, Boehringer Ingelheim’s senior vice president, said in a news release that the company looks forward to continuing to enroll patients, and following up with them, in the interchangeability study called VOLTAIRE-X. Results from the study, of 240 patients, are expected in the second half of 2019.

“The initiation of this study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases through biosimilars,” he said. “With biosimilars, we will have the opportunity to expand treatment options while at the same time providing value to the healthcare system.”

Both the U.S. Food and Drug Administration and the European Medicines Agency have accepted the biosimilar candidate which the study tests, called BI 695501, for regulatory review, according to Boehringer Ingelheim. And researchers presented results of a Phase III study, which demonstrated “clinical equivalence” of BI 695501 and Humira for rheumatoid arthritis patients, at the annual European Congress of Rheumatology conference in Madrid.

“This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar candidate,” Boehringer Ingelheim stated of the new plaque psoriasis study, which just enrolled the patient. It will compare outcomes for patients receiving just Humira and for those who repeatedly switch between Humira and BI 695501. “The study will also assess safety, immunogenicity, and efficacy,” it added.

Biosimilars are biologics that are approved on the basis of being “highly similar to an FDA-approved biological product” and if there are “no clinically meaningful differences in terms of safety and effectiveness from the reference product,” according to the FDA. “Only minor differences in clinically inactive components are allowable in biosimilar products.”

“An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” the FDA added.

Both male and female patients, aged 18 to 80 years, who have had moderate-to-severe chronic plaque psoriasis — with or without psoriatic arthritis — for at least six months are eligible for the VOLTAIRE-X study. More information on the inclusion and exclusion criteria, and contact information to learn more may be found here.